MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008 MACHINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 01/02/2019

Event Type  Death  

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.  clinical review: patients with end-stage renal disease (esrd) on dialysis have greater risk of death than the general population, particularly that of cardiovascular disease.Based on the available information, there is no allegation or objective evidence that a fresenius device or product issue caused or contributed to the reported death.

Event Description

A twitter social media user reported that a fresenius patient died the day after new year's 2019 due to a heart attack, caused by putting off dialysis for one day while the clinic staff had a party.There were no recorded allegations that the death was related to an issue with any fresenius products.No additional information could be obtained as the patient's identity is unknown.

• Brand Name: UNKNOWN-2008
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14480003
• MDR Text Key: 292469105
• Report Number: 0002937457-2022-00819
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death